Dexamethasone side effects: what 294,871 FDA adverse event reports show

Dexamethasone · 1,254 reaction terms · 935,028 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label (Established Pharmacologic Class) · compare the class

Who reports

294,871 reports · 84% serious · 47,727 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.

FDA label, Indications and Usage

What it is

Dexamethasone is a fluorinated steroid that is 9-fluoropregna-1,4-diene substituted by hydroxy groups at positions 11, 17 and 21, a methyl group at position 16 and oxo groups at positions 3 and 20.

PubChem CID 5743 (ChEBI)

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 1Likely indication confounding 11Lab value / disease marker 2Not in label — unassessed 26

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,214 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Lymphoid tissue hypoplasia	141	1,625.2 717.9–3,678.9ROR 1,626.0 · calibrated p 2e-15 ✓	66.7 EB05 58.0 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 17.6 (14.6–21.1)	Likely indication confounding shares a disease stem with the indications wording	serious n=141 · ♀ 0% (drug 49%) · 100% consumer	no trial arm names this drug
Thymus hypoplasia	145	401.1 262.4–613.2ROR 401.3 · calibrated p 5e-12 ✓	59.4 EB05 51.7 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 16.8 (14.1–20.1)	Likely indication confounding shares a disease stem with the indications wording	serious n=145 · ♀ 0% (drug 49%) · 100% consumer	no trial arm names this drug
Plasma cell leukaemia	319	81.1 69.0–95.3ROR 81.2 · calibrated p 6e-7 ✓	37.8 EB05 34.4 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: only this drug	Likely indication confounding shares a disease stem with the indications wording	serious n=318 · 91% clinician	no trial arm names this drug
Plasma cell myeloma refractory	643	69.9 62.7–78.0ROR 70.1 · calibrated p 2e-6 ✓	35.2 EB05 33.0 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: PRR 2,757.4 (1,726.4–4,404.0)	Not in label — unassessed	serious n=640 · 91% clinician	no trial arm names this drug
Rhinocerebral mucormycosis	155	58.6 47.3–72.5ROR 58.6 · calibrated p 6e-6 ✓	32.1 EB05 28.0 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: only this drug	Not in label — unassessed	serious n=155 · ♀ 0% (drug 49%) · 100% clinician	no trial arm names this drug
Plasma cell myeloma recurrent	1,354	50.0 46.6–53.6ROR 50.2 · calibrated p 1e-5 ✓	29.4 EB05 28.1 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 6,532.1 (3,990.9–10,691.6)	Not in label — unassessed	serious n=1,238	no trial arm names this drug
Plasmacytoma	738	45.7 41.7–50.2ROR 45.8 · calibrated p 2e-5 ✓	27.9 EB05 26.3 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 7,120.7 (3,548.1–14,290.7)	Not in label — unassessed	serious n=716 · 91% clinician	no trial arm names this drug
Disseminated aspergillosis	175	42.0 34.8–50.7ROR 42.0 · calibrated p 4e-5 ✓	26.5 EB05 23.3 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: only this drug	Not in label — unassessed	serious n=175 · ♀ 0% (drug 49%)	no trial arm names this drug
Plasma cell myeloma	14,170	40.1 39.3–41.0ROR 42.1 · calibrated p 4e-5 ✓	25.8 EB05 25.4 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 285.5 (276.1–295.2)	Not in label — unassessed	age-adj. PRR 30.4 · serious PRR 17.8	no trial arm names this drug
Light chain analysis increased	347	36.0 31.6–41.0ROR 36.1 · calibrated p 1e-4 ✓	24.0 EB05 22.0 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: only this drug	Not in label — unassessed	serious n=222	no trial arm names this drug
Monoclonal immunoglobulin present	240	32.2 27.7–37.6ROR 32.3 · calibrated p 2e-4 ✓	22.3 EB05 20.0 · IC025 +4.2 3/3 methods agree vs other Corticosteroids: PRR 2,315.7 (1,145.0–4,683.3)	Lab value / disease marker	serious n=159	no trial arm names this drug
B-cell type acute leukaemia	191	25.5 21.6–30.1ROR 25.5 · calibrated p 7e-4 ✓	18.9 EB05 16.7 · IC025 +3.9 3/3 methods agree vs other Corticosteroids: only this drug	Likely indication confounding shares a disease stem with the indications wording	serious n=191 · 100% clinician	no trial arm names this drug
Diffuse large b-cell lymphoma refractory	244	25.0 21.6–29.0ROR 25.1 · calibrated p 7e-4 ✓	18.6 EB05 16.7 · IC025 +4.0 3/3 methods agree vs other Corticosteroids: PRR 33.9 (29.2–39.4)	Likely indication confounding shares a disease stem with the indications wording	serious n=240 · 100% clinician	no trial arm names this drug
Diffuse large b-cell lymphoma recurrent	529	23.0 20.8–25.4ROR 23.0 · calibrated p 0.001 ✓	17.5 EB05 16.3 · IC025 +4.0 3/3 methods agree vs other Corticosteroids: PRR 21.3 (19.4–23.4)	Likely indication confounding shares a disease stem with the indications wording	serious n=528	no trial arm names this drug
C-reactive protein	213	21.6 18.5–25.2ROR 21.6 · calibrated p 0.001 ✓	16.7 EB05 14.9 · IC025 +3.8 3/3 methods agree vs other Corticosteroids: PRR 2.7 (2.4–3.1)	Lab value / disease marker	serious n=213 · ♀ 100% (drug 49%) · 100% clinician	no trial arm names this drug
Secondary immunodeficiency	260	19.6 17.0–22.5ROR 19.6 · calibrated p 0.002 ✓	15.4 EB05 13.9 · IC025 +3.7 3/3 methods agree vs other Corticosteroids: PRR 5.8 (5.1–6.5)	Labeled (related wording) related wording	serious n=258	no trial arm names this drug
Pseudomonal sepsis	355	17.7 15.8–19.9ROR 17.8 · calibrated p 0.003 ✓	14.3 EB05 13.1 · IC025 +3.6 3/3 methods agree vs other Corticosteroids: PRR 12.1 (10.8–13.5)	Not in label — unassessed	serious n=355	no trial arm names this drug
Hypofibrinogenaemia	194	17.6 15.0–20.6ROR 17.6 · calibrated p 0.004 ✓	14.2 EB05 12.6 · IC025 +3.5 3/3 methods agree vs other Corticosteroids: PRR 8.9 (7.7–10.3)	Not in label — unassessed	serious n=191 · ♀ 0% (drug 49%) · 100% clinician	no trial arm names this drug
Cytomegalovirus chorioretinitis	377	17.1 15.3–19.1ROR 17.1 · calibrated p 0.004 ✓	13.9 EB05 12.7 · IC025 +3.6 3/3 methods agree vs other Corticosteroids: PRR 13.0 (11.7–14.5)	Not in label — unassessed	serious n=375 · 93% clinician	no trial arm names this drug
Parainfluenzae virus infection	302	17.0 15.0–19.3ROR 17.1 · calibrated p 0.004 ✓	13.8 EB05 12.6 · IC025 +3.6 3/3 methods agree vs other Corticosteroids: PRR 13.8 (12.2–15.6)	Not in label — unassessed	serious n=301	no trial arm names this drug
Mycobacterium chelonae infection	143	16.9 14.1–20.3ROR 16.9 · calibrated p 0.004 ✓	13.7 EB05 11.9 · IC025 +3.4 3/3 methods agree vs other Corticosteroids: PRR 4.7 (4.0–5.6)	Not in label — unassessed	serious n=143	no trial arm names this drug
Osteolysis	392	16.6 14.9–18.5ROR 16.6 · calibrated p 0.005 ✓	13.6 EB05 12.5 · IC025 +3.6 3/3 methods agree vs other Corticosteroids: PRR 383.0 (300.9–487.6)	Not in label — unassessed	serious n=388	no trial arm names this drug
Deep vein thrombosis postoperative	352	15.4 13.7–17.2ROR 15.4 · calibrated p 0.006 ✓	12.7 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Corticosteroids: PRR 2.0 (1.8–2.3)	Not in label — unassessed	serious n=352 · ♀ 100% (drug 49%) · 100% clinician	no trial arm names this drug
Febrile bone marrow aplasia	708	14.3 13.2–15.5ROR 14.3 · calibrated p 0.008 ✓	12.0 EB05 11.3 · IC025 +3.5 3/3 methods agree vs other Corticosteroids: PRR 11.5 (10.6–12.4)	Likely indication confounding shares a disease stem with the indications wording	serious n=708 · 100% clinician	no trial arm names this drug
Neutropenic infection	162	14.1 11.9–16.7ROR 14.2 · calibrated p 0.009 ✓	11.8 EB05 10.4 · IC025 +3.3 3/3 methods agree vs other Corticosteroids: only this drug	Not in label — unassessed	serious n=162 · 100% clinician	no trial arm names this drug
Neutropenic sepsis	1,198	14.1 13.3–15.0ROR 14.2 · calibrated p 0.009 ✓	11.9 EB05 11.3 · IC025 +3.5 3/3 methods agree vs other Corticosteroids: PRR 23.5 (22.1–25.1)	Not in label — unassessed	serious PRR 8.1 · 93% clinician	no trial arm names this drug
Acute lymphocytic leukaemia recurrent	429	14.0 12.6–15.5ROR 14.0 · calibrated p 0.009 ✓	11.8 EB05 10.9 · IC025 +3.4 3/3 methods agree vs other Corticosteroids: PRR 1,141.9 (784.1–1,662.8)	Likely indication confounding shares a disease stem with the indications wording	serious n=425 · 91% clinician	no trial arm names this drug
Mucormycosis	409	13.3 11.9–14.7ROR 13.3 · calibrated p 0.012 ✓	11.3 EB05 10.4 · IC025 +3.3 3/3 methods agree vs other Corticosteroids: PRR 15.6 (14.0–17.3)	Not in label — unassessed	serious n=407 · 100% clinician	no trial arm names this drug
Strongyloidiasis	245	12.5 10.9–14.3ROR 12.5 · calibrated p 0.015 ✓	10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree vs other Corticosteroids: PRR 7.3 (6.4–8.3)	Not in label — unassessed	serious n=245 · ♀ 0% (drug 49%) · 100% clinician	no trial arm names this drug
Escherichia bacteraemia	343	12.2 10.9–13.7ROR 12.2 · calibrated p 0.016 ✓	10.5 EB05 9.6 · IC025 +3.2 3/3 methods agree vs other Corticosteroids: PRR 23.5 (20.8–26.5)	Not in label — unassessed	serious n=342 · 92% clinician	no trial arm names this drug
Cardiac amyloidosis	160	12.1 10.2–14.3ROR 12.1 · calibrated p 0.017 ✓	10.4 EB05 9.1 · IC025 +3.1 3/3 methods agree vs other Corticosteroids: only this drug	Not in label — unassessed	serious n=160 · ♀ 100% (drug 49%) · 100% clinician	no trial arm names this drug
Cytopenia	1,729	11.9 11.3–12.5ROR 11.9 · calibrated p 0.017 ✓	10.3 EB05 9.9 · IC025 +3.3 3/3 methods agree vs other Corticosteroids: PRR 36.2 (34.2–38.3)	Likely indication confounding term in indications	serious PRR 7.1	no trial arm names this drug
Multiple myeloma	670	11.6 10.7–12.6ROR 11.6 · calibrated p 0.019 ✓	10.0 EB05 9.4 · IC025 +3.2 3/3 methods agree vs other Corticosteroids: PRR 3,447.8 (2,067.2–5,750.5)	Not in label — unassessed	serious n=671 · 100% clinician	no trial arm names this drug
Autonomic neuropathy	142	11.4 9.6–13.7ROR 11.4 · calibrated p 0.021 ✓	9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree vs other Corticosteroids: only this drug	Not in label — unassessed	serious n=142 · ♀ 0% (drug 49%) · 100% clinician	no trial arm names this drug
Febrile infection	161	11.4 9.7–13.5ROR 11.4 · calibrated p 0.021 ✓	9.8 EB05 8.6 · IC025 +3.0 3/3 methods agree vs other Corticosteroids: PRR 956.0 (543.3–1,681.9)	Not in label — unassessed	serious n=157 · 100% clinician	no trial arm names this drug
Pneumonia influenzal	166	11.3 9.6–13.3ROR 11.3 · calibrated p 0.022 ✓	9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree vs other Corticosteroids: only this drug	Likely indication confounding shares a disease stem with the indications wording	serious n=166 · 100% clinician	no trial arm names this drug
Amyloidosis	239	11.3 9.8–12.9ROR 11.3 · calibrated p 0.022 ✓	9.8 EB05 8.7 · IC025 +3.1 3/3 methods agree vs other Corticosteroids: only this drug	Not in label — unassessed	serious n=233 · ♀ 0% (drug 49%)	no trial arm names this drug
Febrile neutropenia	9,044	11.1 10.9–11.4ROR 11.4 · calibrated p 0.020 ✓	9.7 EB05 9.5 · IC025 +3.2 3/3 methods agree vs other Corticosteroids: PRR 20.6 (20.2–21.1)	Not in label — unassessed	age-adj. PRR 9.4 · serious PRR 6.6 · 94% clinician	no trial arm names this drug
Listeriosis	149	11.0 9.2–13.1ROR 11.0 · calibrated p 0.024 ✓	9.5 EB05 8.2 · IC025 +3.0 3/3 methods agree vs other Corticosteroids: PRR 28.2 (23.4–34.0)	Not in label — unassessed	serious n=148 · ♀ 0% (drug 49%) · 100% clinician	no trial arm names this drug
Acute lymphocytic leukaemia	380	10.9 9.8–12.1ROR 10.9 · calibrated p 0.024 ✓	9.5 EB05 8.7 · IC025 +3.1 3/3 methods agree vs other Corticosteroids: PRR 3,666.5 (1,820.5–7,384.2)	Likely indication confounding shares a disease stem with the indications wording	serious n=369 · 100% clinician	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Neutropenia / agranulocytosis	22,319	7.06.9–7.0	signal
Thrombocytopenia	16,483	5.75.6–5.8	signal
Anaemia	12,714	3.13.1–3.2	signal
Venous thromboembolism	8,838	3.02.9–3.0	signal
Serious infection	29,813	2.82.8–2.8	signal
Opportunistic infection	4,716	2.52.4–2.6	signal
Osteonecrosis	1,934	2.42.3–2.5	signal
Hyponatraemia	2,341	2.12.0–2.2	signal
Interstitial lung disease	2,754	2.12.0–2.2	raised
Kidney injury	12,355	1.91.9–2.0	raised
Liver injury	7,334	1.71.7–1.8	raised
Arrhythmia / qt	4,660	1.71.7–1.8	raised
Anaphylaxis / angioedema	2,802	1.61.5–1.7	raised
Heart failure	3,986	1.61.5–1.6	raised
Severe cutaneous reaction	1,622	1.61.5–1.6	raised
Pancreatitis	1,426	1.31.2–1.3	raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Dexamethasone only as a background or rescue medication (NCT02625181, NCT01190930); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Off label use (used outside approved label)	22,597	1.9 1.9–1.9ROR 1.9 · calibrated p 0.915	1.9 EB05 1.8 · IC025 +0.9 vs other Corticosteroids: PRR 6.9 (6.9–7.0)	Reporting / coding artifact	age-adj. PRR 1.8 · serious PRR 2.1	no trial arm names this drug
Fatigue (tiredness)	17,261	1.6 1.6–1.6ROR 1.6 · calibrated p 0.725	1.6 EB05 1.6 · IC025 +0.6 vs other Corticosteroids: PRR 8.8 (8.8–8.9)	Not in label — unassessed	age-adj. PRR 1.3 · serious PRR 1.4	no trial arm names this drug
Diarrhoea (diarrhea)	17,079	1.9 1.9–1.9ROR 2.0 · calibrated p 0.927	1.9 EB05 1.9 · IC025 +0.9 vs other Corticosteroids: PRR 11.4 (11.3–11.5)	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.7	no trial arm names this drug
Plasma cell myeloma	14,170	40.1 39.3–41.0ROR 42.1 · calibrated p 4e-5 ✓	25.8 EB05 25.4 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 285.5 (276.1–295.2)	Not in label — unassessed	age-adj. PRR 30.4 · serious PRR 17.8	no trial arm names this drug
Nausea	14,034	1.3 1.2–1.3ROR 1.3 · calibrated p 0.496	1.3 EB05 1.2 · IC025 +0.3 vs other Corticosteroids: PRR 9.0 (8.9–9.1)	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 1.3	no trial arm names this drug
Pneumonia (lung infection)	13,684	3.1 3.0–3.2ROR 3.2 · calibrated p 0.564	3.0 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 11.1 (11.0–11.2)	Likely indication confounding term in indications	age-adj. PRR 2.6 · serious PRR 2.1	no trial arm names this drug
Death	13,410	1.1 1.1–1.1ROR 1.1 · calibrated p 0.382	1.1 EB05 1.1 · IC025 +0.1 vs other Corticosteroids: PRR 20.8 (20.5–21.1)	Outcome field, not a reaction	age-adj. PRR 1.0 · serious PRR 0.8	no trial arm names this drug
Drug ineffective (drug did not work)	13,116	0.7 0.7–0.7ROR 0.7 · calibrated p 0.126	0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other Corticosteroids: PRR 4.3 (4.3–4.4)	Reporting / coding artifact	age-adj. PRR 1.0 · serious PRR 1.2	no trial arm names this drug
Neutropenia (low neutrophils (infection-fighting cells))	11,606	6.6 6.5–6.7ROR 6.8 · calibrated p 0.107	6.1 EB05 6.0 · IC025 +2.6 3/3 methods agree vs other Corticosteroids: PRR 30.7 (30.2–31.3)	Not in label — unassessed	age-adj. PRR 5.2 · serious PRR 4.1 · 93% clinician	no trial arm names this drug
Pyrexia (fever)	10,996	2.3 2.3–2.3ROR 2.4 · calibrated p 0.880	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 7.7 (7.6–7.8)	Not in label — unassessed	age-adj. PRR 2.1 · serious PRR 1.8	no trial arm names this drug
Thrombocytopenia (low platelets)	10,626	7.4 7.2–7.5ROR 7.6 · calibrated p 0.077	6.8 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Corticosteroids: PRR 27.8 (27.3–28.3)	Likely indication confounding term in indications	age-adj. PRR 5.5 · serious PRR 4.6 · 90% clinician	no trial arm names this drug
Dyspnoea (shortness of breath)	10,248	1.3 1.3–1.3ROR 1.3 · calibrated p 0.511	1.3 EB05 1.3 · IC025 +0.3 vs other Corticosteroids: PRR 6.2 (6.1–6.3)	Not in label — unassessed	age-adj. PRR 1.2 · serious PRR 1.1	no trial arm names this drug
Febrile neutropenia	9,044	11.1 10.9–11.4ROR 11.4 · calibrated p 0.020 ✓	9.7 EB05 9.5 · IC025 +3.2 3/3 methods agree vs other Corticosteroids: PRR 20.6 (20.2–21.1)	Not in label — unassessed	age-adj. PRR 9.4 · serious PRR 6.6 · 94% clinician	no trial arm names this drug
Anaemia (low red blood cells)	9,025	3.5 3.4–3.6ROR 3.6 · calibrated p 0.470	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 16.8 (16.5–17.1)	Likely indication confounding term in indications	age-adj. PRR 2.5 · serious PRR 2.4	no trial arm names this drug
Vomiting	8,802	1.3 1.3–1.4ROR 1.4 · calibrated p 0.543	1.3 EB05 1.3 · IC025 +0.4 vs other Corticosteroids: PRR 7.4 (7.2–7.5)	Not in label — unassessed	age-adj. PRR 1.2 · serious PRR 1.2	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Plasma cell myeloma refractory — n=643, PRR 69.9
Rhinocerebral mucormycosis — n=155, PRR 58.6
Plasma cell myeloma recurrent — n=1,354, PRR 50.0
Plasmacytoma — n=738, PRR 45.7
Disseminated aspergillosis — n=175, PRR 42.0
Plasma cell myeloma — n=14,170, PRR 40.1
Light chain analysis increased — n=347, PRR 36.0
Pseudomonal sepsis — n=355, PRR 17.7
Hypofibrinogenaemia — n=194, PRR 17.6
Cytomegalovirus chorioretinitis — n=377, PRR 17.1

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Dexamethasone?

In FDA FAERS, the most frequently co-reported reaction terms for Dexamethasone are fatigue, diarrhoea, plasma cell myeloma, nausea, pneumonia, neutropenia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Dexamethasone have an FDA boxed warning?

No. The FDA label retrieved for Dexamethasone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Dexamethasone causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 05c77a4c-c508-babd-e063-6294a90a450a, effective 20240308; matched on openfda.generic_name.exact:"DEXAMETHASONE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 5743 description (ChEBI)
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,254 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query DEXAMETHASONE, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.